Airway Management Clinical Trial
Official title:
A Comparison of the Intubating Laryngeal Mask FASTRACH™ and the Intubating Laryngeal Mask Ambu Aura-i™
The intubating laryngeal mask Fastrach™ is considered a gold standard for blind intubation as well as for fibreoptic guided intubation via a laryngeal mask. Recently, a single use version of the mask has been introduced. The Fastrach single use laryngeal mask is beng compared to the new, low-priced single use intubating laryngeal mask Ambu Aura-i™.
Eighty patients undergoing general anaesthesia with planned tracheal intubation for elective
surgical procedures are enrolled in the study after checking for inclusion and exclusion
criteria. Patients are randomised to either LMA group for blind tracheal intubation with
either a standard PVC tracheal tube, or a specifically for the LMA Fastrach developed tube,
yielding 4 subgroups.
After a standardised anaesthesia induction, blind intubation is performed in each study
group. Different time intervals are documented, such as time to first adequate lung
ventilation, or f.e. time for laryngeal mask placement. A crossover-design is performed
after unsuccessful intubation, using the alternate LMA or the other tracheal tube. LMA
placement is visualised by fibreoptic control.
An estimated success rate for blind intubation of 60% in the Aura-i group versus 90% in the
Fastrach group yields a sample size of n= 38. To compensate for dropouts, n=40 subjects are
enrolled in each group.
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